Cleared Traditional

K864891 - API UNISCEPT (TM) KB

K864891 is the FDA 510(k) clearance for API UNISCEPT (TM) KB by Analytical Products, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K864891 · Analytical Products, Inc. · Microbiology device
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Feb 1987
Decision
67d
Days
Class 2
Risk

K864891 is an FDA 510(k) clearance for the API UNISCEPT (TM) KB. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on February 20, 1987 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Analytical Products, Inc. devices

Submission Details

510(k) Number K864891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1986
Decision Date February 20, 1987
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 102d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 168
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K864891.
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
K874876 · Baxter Healthcare Corp · Jan 1988
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1987
SENSIR SYSTEM
K870719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987
SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL
K861187 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL
K861186 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1986
SENSITITRE SUSCEPTIBILITY PLATES
K860753 · Gibco Laboratories Life Technologies, Inc. · May 1986